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Information is also accessible through the patient and families tab. Family friendly summaries are created and reviewed by our advocacy partners. The information is updated to the best of our knowledge but might not reflect the latest information. Note that most studies are only available at a limited number of sites, please click on ‘further information’ for details. Studies, particularly early phase trials, may also temporarily close to enrolment or not have slots available for all treatment groups. In all cases, study teams at individual C17 centres will have the most up-to-date information.

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Title
Status

 

SU2C-SARC032 - A Phase II Randomized Controlled Trial of Neoadjuvant Pembrolizumab With Radiotherapy and Adjuvant Pembrolizumab in Patients With High-Risk, Localized Soft Tissue Sarcoma of the Extremity

Closed to enrollment

More information

SU2C-SARC032 - A Phase II Randomized Controlled Trial of Neoadjuvant Pembrolizumab With Radiotherapy and Adjuvant Pembrolizumab in Patients With High-Risk, Localized Soft Tissue Sarcoma of the Extremity

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DiagnosisSoft Tissue SarcomaStudy StatusClosed to enrollment
PhaseII
Age≥ 12 yearsRandomisationYES
Line of treatmentFirst line treatment, Disease relapse or progression
Routes of Treatment AdministrationDrug: Pembrolizumab (KEYTRUDA®) Pembrolizumab will be administered at 200 mg intravenously every 3 weeks for patients on the treatment arm. Participants not on the treatment arm will receive standard of care radiotherapy followed by surgical resection.
Last Posted Update2024-04-09
ClinicalTrials.gov #NCT03092323
International Sponsor
Sarcoma Alliance for Research through Collaboration
Principal Investigators for Canadian Sites
McGill University Health Centre - Please email research contact
Centres
Medical contact
N/A
Social worker/patient navigator contact
N/A
Clinical research contact
N/A

 

 

Study Description

This study is trying to find out if adding a new drug (pembrolizumab) to the standard treatment for soft tissue sarcoma, makes the treatment work better. Researchers will compare two groups: one group gets the standard treatment of radiation before surgery, and the other group gets pembrolizumab with radiation before surgery, plus more pembrolizumab after surgery for a year, to see which group does better.

Inclusion Criteria
  • Participant must be 12 years of age or older
  • Participant must have an applicable sarcoma diagnosis in their extremity (patients with skin cancer, carcinoma or low-risk prostate cancer may also be eligible)
  • Participant should be able to be up and about throughout the day with minimal restriction 
  • Must meet all lab and organ function requirements within 10 days of starting on study 
  • Participant or parent/caregiver must be willing to sign an informed consent and agree to the study requirements 
  • If participants are able to have children, they must agree to use an effective method of birth control while on study and for 120 days after the last dose of pembrolizumab. 

Other inclusion criteria and exclusion criteria apply and will be discussed with you by the study team